Budesonide / Formoterol Fumarate Dihydrate

Budesonide/Formoterol Fumarate Dihydrate is an FDA-approved medication that combines Budesonide and Formoterol Fumarate Dihydrate. It is used to manage asthma and chronic obstructive pulmonary disease (COPD) in adults needing corticosteroids and long-acting bronchodilator therapy. Budesonide reduces airway inflammation, while Formoterol relaxes airway muscles, easing breathing. Common strengths include 80 mcg or 160 mcg for Budesonide and 4.5 mcg or 9 mcg for Formoterol per inhalation. It is administered via oral inhalation and is not suitable for sudden asthma attacks. Side effects may include headache, cough, and mouth fungal infections. Store at room temperature and follow your healthcare provider’s instructions diligently for safe and effective usage.

Budesonide/Formoterol Fumarate Dihydrate is an FDA-approved medication combining the active ingredients Budesonide and Formoterol Fumarate Dihydrate. Budesonide is a corticosteroid that reduces inflammation in the airways, while Formoterol is a long-acting beta-agonist that helps relax the muscles around the airways, making breathing easier. It is primarily used to manage asthma and chronic obstructive pulmonary disease (COPD) in adults requiring corticosteroids and long-acting bronchodilator therapy. It helps control symptoms such as wheezing, breath shortness, coughing, and tight chest by reducing airway inflammation and improving airflow.

Budesonide is available in strengths like 80 mcg and 160 mcg per inhalation, while Formoterol Fumarate Dihydrate is available in strengths such as 4.5 mcg or 9 mcg per inhalation. A healthcare professional should determine the dosage and administration method. It is typically taken via oral inhalation using a metered-dose inhaler or a dry powder inhaler. It is suitable for adults and should not be used as a rescue inhaler for sudden asthma attacks.

Common side effects of Budesonide-Formoterol Fumarate Dihydrate may include headache, cough, and mouth fungal infections. It’s essential to rinse the mouth with water after each use to reduce the risk of oral fungal infections. In case of a missed dose, please take it as soon as you remember, but do not double the dose to catch up. If an overdose is suspected, seek medical attention immediately. Store it at room temperature, away from moisture and heat. Follow all instructions your healthcare provider provides for safe and effective use of this medication.

Budesonide/Formoterol Fumarate Dihydrate is used for the treatment of:

• Asthma symptoms in both adults and children aged 6 years and older.
• Symptoms of chronic obstructive pulmonary disease (COPD) include chronic bronchitis and emphysema.

[Important Warning: Budesonide Formoterol Fumarate Dihydrate is not intended for treating acute asthma attacks or bronchospasms. For sudden symptoms, a rescue inhaler should be used instead.]

Dosage

Strengths and Forms

Budesonide-Formoterol Fumarate Dihydrate comes in inhalation forms:

• Metered-Dose Inhaler (MDI): It comes with the following strengths: 
  • 80 mcg Budesonide/4.5 mcg Formoterol
  • 160 mcg Budesonide/4.5 mcg Formoterol
• Dry Powder Inhaler (DPI): It also comes with the strengths: 
  • 80 mcg Budesonide/4.5 mcg Formoterol
  • 160 mcg Budesonide/4.5 mcg Formoterol

Recommended Dosage for Asthma

Adults (18 Years and Older):

The starting dosage is two inhalations (puffs) of either strength formulation, twice daily, 12 hours apart.

Children (12–17 Years):

The starting dosage is two inhalations (puffs) of either strength formulation, twice daily, 12 hours apart.

Children (6–11 Years):

The typical dosage is two inhalations (puffs) of the 80-mcg Budesonide/4.5-mcg Formoterol formulation twice daily, 12 hours apart.

Children (0–5 Years):

Not recommended.

Recommended Dosage for COPD

Adults (18 Years and Older):

The starting dosage is two inhalations (puffs) of 160 mcg Budesonide/4.5 mcg Formoterol, twice daily, 12 hours apart.

Children (0–17 Years):

It is not recommended for children under 18 years for COPD.

[Note: These recommendations may vary depending on person to person. Discuss it with your doctor, and they’ll customize your Budesonide/Formoterol Fumarate Dihydrate dosage accordingly.]

Here’s how to take Budesonide/Formoterol Fumarate Dihydrate:

Step 1. Shake the inhaler well before each use.

Step 2. Exhale entirely, away from the inhaler, to ensure maximum lung capacity for medication absorption.

Step 3. Place the mouthpiece between your lips, ensuring a tight seal. Press down on the canister to release one puff while inhaling deeply and slowly.

Step 4. Hold your breath for about 10 seconds to allow the medication to reach deep into your lungs.

Step 5. Exhale slowly through your mouth.

Step 6. If your prescribed dosage is more than one puff, wait about one minute before repeating the process.

Step 7. After inhalation, rinse your mouth with water to prevent potential side effects like throat irritation or oral fungal infections.

Step 8. Close the inhaler’s cap tightly after use to prevent contamination. If using a dry powder inhaler, clean it regularly per the manufacturer’s instructions.

[Note: Your doctor will decide the correct amount of Budesonide-Formoterol Fumarate Dihydrate for you based on your condition, following guidelines and studies on the drug. They’ll adjust it as needed over time.]

Budesonide/Formoterol Fumarate Dihydrate combines Budesonide, a corticosteroid, with Formoterol Fumarate Dihydrate, a long-acting beta agonist. Budesonide reduces inflammation in the airways, while Formoterol dilates the airway muscles, facilitating easier breathing. They provide a dual-action approach to managing asthma and chronic obstructive pulmonary disease (COPD) symptoms. Budesonide/Formoterol Fumarate Dihydrate helps control wheezing, breath shortness, coughing, and tight chest by reducing airway inflammation and improving airflow, thus promoting better respiratory function.

Common side effects of Budesonide Formoterol Fumarate Dihydrate may include:

• Feeling nervous
• Uncontrolled shaking
• Dry mouth
• Headaches
• Muscle cramps
• Vomiting
• Nausea
• Diarrhea
• Dizziness
• Nasal congestion
• Extreme tiredness
• Sleep issues
• Sore throat

Mild side effects of Budesonide Formoterol Fumarate Dihydrate may include:

• Throat irritation
• Headache
• Cough
• Fungal infections in the mouth (oral thrush)
• Nausea or vomiting
• Tremor or shakiness
• Nervousness or anxiety

Serious side effects of Budesonide Formoterol Fumarate Dihydrate may include:

• Swelling in your tongue, throat, eyes, lips or face, it’s urgent.
• Breathing difficulties
• Skin reactions like rashes, hives or itching
• Heart issues like pounding, fast, or irregular heartbeat, or chest pain.
• Fainting

[Note: Remember, this list may not cover all possible side effects of Budesonide-Formoterol Fumarate Dihydrate. Always consult with your healthcare provider for medical advice about side effects.]

• Asthma Warning: Using Formoterol alone in adults with asthma may increase the risk of asthma-related death, while children and adolescents may face a higher likelihood of asthma-related hospitalization. However, when used in combination with drugs like Budesonide, these risks were not observed.
• Usage Warning: This medication does not immediately relieve sudden asthma symptoms like shortness of breath. Ensure you have a rescue inhaler available for such situations. If you do not have one, consult your doctor for a prescription.
• Emergency Help Warning: If your breathing worsens suddenly or your rescue inhaler does not alleviate symptoms, seek emergency medical attention promptly.
• LABA Interaction Warning: Do not use other medications containing long-acting beta2-agonists (LABAs) while using this drug, as it may lead to adverse effects such as chest pain, increased blood pressure, rapid heart rate, and nervousness.
• Allergy Warning: This drug can trigger severe allergic reactions characterized by symptoms like skin rash, hives, swelling of the face, and difficulty breathing, among others. Seek immediate medical help if you experience these symptoms. Do not retake this drug if you’ve had an allergic reaction to it in the past.

Warnings for People with Certain Health Conditions

• It may exacerbate heart conditions. Inform your doctor if you have heart disease.
• Notify your doctor if you have a history of seizure disorders.
• This drug may affect thyroid activity. Discuss its safety with your doctor if you have thyroid issues.
• Monitor blood sugar levels closely, as this medication may elevate them.
• This drug weakens the immune system, raising the risk of infections. Discuss its safety if you have specific immune disorders.
• Regular monitoring is necessary as this medication may decrease bone strength or cause Osteoporosis.
• Regular eye check-ups are advised, as this drug may cause eye issues like increased eye pressure, glaucoma, and cataracts.
• Close monitoring is necessary as the liver metabolizes this drug, potentially increasing the risk of side effects.

Warnings for Other Groups

• Use only if the benefits outweigh the risks, and consult your doctor if pregnant or planning pregnancy.
• Discuss potential risks with your doctor if you are breastfeeding, as this drug may pass into breast milk.
• Safety and effectiveness are not established for children under the age of 6 with asthma and children under 18 years with COPD.

• Allergies: Tell your doctor if you’re allergic to Formoterol, other bronchodilators like albuterol, or any sympathomimetic drugs (like epinephrine). Some inactive ingredients in Budesonide-Formoterol Fumarate Dihydrate might also cause allergic reactions.
• Medical History: Share medical history with your doctor or healthcare provider, especially if you have heart diseases (like irregular heartbeat or angina), high blood pressure, overactive thyroid, seizures, diabetes, metabolism issues (like ketoacidosis), artery swelling (aneurysm), or adrenal gland tumors (pheochromocytoma).
• Heart Rhythm: Budesonide-Formoterol Fumarate Dihydrate can affect heart rhythm (known as QT prolongation), which might lead to serious, sometimes fatal, irregular heartbeats and symptoms like severe dizziness or fainting. Immediate medical attention is required if these occur.
• Risk Factors for QT Prolongation: The risk is higher if you have certain heart conditions, a family history of heart issues, or low levels of potassium or magnesium in your blood. It can also increase if you take certain medications, including diuretics. Older adults may be more sensitive to the side effects, particularly QT prolongation.
• Other Drugs and Conditions: Inform your doctor about all your medications, as some can increase the risk of QT prolongation. Be cautious if you experience severe sweating, diarrhea, or vomiting.
• Dizziness: This medication can cause dizziness. Alcohol and marijuana can worsen this effect. Avoid driving or operating machinery until you can do so safely. Limit alcohol consumption and discuss marijuana use with your doctor.
• Surgery: Before any surgery, inform your healthcare provider or dentist about all the products you use, including prescribed and over-the-counter drugs and herbal products.
• Pregnancy & Breastfeeding: Use Budesonide-Formoterol Fumarate Dihydrate during pregnancy only if needed. It’s not known if Formoterol passes into breast milk. Discuss the risks & benefits with your doctor.

Budesonide/Formoterol Fumarate Dihydrate Contraindications

• Hypersensitivity to Formoterol, Budesonide, or any ingredient of the formulation.
• Primary treatment for status asthmaticus or other acute episodes of asthma or COPD.
• Allergenic cross-reactivity for corticosteroids or sympathomimetics.

If you forget to take a dose, take it when you remember. However, if it’s nearly time for your next planned dose, skip the missed one and continue your usual dosing timetable. Avoid taking double doses to compensate for the missed one.

[Note: If you need a Budesonide/Formoterol Fumarate Dihydrate dose and are unsure when to take the next one, immediately consult your doctor or pharmacist.]

Overdosing on Budesonide/Formoterol Fumarate Dihydrate may lead to symptoms like chest pain, irregular heartbeats, tremors, seizures, and severe headaches.

[Note: If you consumed more than the recommended Budesonide/Formoterol Fumarate Dihydrate dose, get medical help immediately or call the Poison Help line at 1-800-222-1222.]

• Keep the unused vials in their foil pouches away from light and heat.
• You can store them in the fridge or at room temperature, but only for 3 months.
• Keep the medication where children can’t get to it.
• While disposing of it safely, throw away the used vial and its top where children can’t reach it.
• Regularly clean the nebulizer as per the manufacturer’s instructions. Ask your doctor or pharmacist if you need help with how to do this.

[Note: Discuss with your healthcare professional the proper disposal of unused Budesonide-Formoterol Fumarate Dihydrate and any questions you may have regarding its storage.]

There are 792 drugs known to interact with Budesonide Formoterol Fumarate Dihydrate. Some of them are:

• Aspirin
• Augmentin (amoxicillin/clavulanate)
• Cymbalta (duloxetine)
• Lyrica (pregabalin)
• Metoprolol
• Singulair (montelukast)
• Xanax (alprazolam)
• Fish Oil (omega-3 polyunsaturated fatty acids)
• Vitamin B12 (cyanocobalamin)
• Vitamin C (ascorbic acid)
• Vitamin D3 (cholecalciferol)

[Note: This isn’t a complete list, and there could be other drugs that interact with (drug name). Tell your doctor any prescription, over-the-counter medicines, and herbal products you’re taking.]

• Advair Diskus (fluticasone/salmeterol)
• Advair HFA (fluticasone/salmeterol)
• Asmanex HFA (mometasone)
• Breo Ellipta (fluticasone/vilanterol)
• Breztri Aerosphere (budesonide/glycopyrrolate/formoterol)

[Note: Your doctor will choose the best Budesonide/Formoterol Fumarate Dihydrate alternative for you. Only use these alternative medications after consulting your healthcare provider. Taking them by yourself may cause serious side effects.]

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